Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the FLOW-i Anesthesia System, a medical device intended for administering inhalation anesthesia to neonatal and adult patients. The recall involves 1,641 units distributed worldwide, including in the United States and numerous international countries.
The recall is due to a defect where the patient cassette can become dislodged. This dislodgement can result in gas leakage within the system's internal circuit, which may lead to a stop in ventilation for the patient.
Healthcare providers should contact Maquet Cardiovascular for instructions on how to address the defect. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
Distribution
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